MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2017-01-10 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..
[64356143]
Device still implanted; not returned.
Patient Sequence No: 1, Text Type: N, H10
[64356144]
This subject is a participant in the (b)(6) clinical trial. This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014. Subject noticed a flashing red light that was reported on (b)(6) 2016. During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead. Therapy is not being delivered.
Patient Sequence No: 1, Text Type: D, B5
[77855508]
Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[77855509]
This subject is a participant in the recharge clinical trial. This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014. Subject noticed a flashing red light that was reported on (b)(6) 2016. During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead. Therapy is not being delivered. Supplement 001: subject underwent revision of the maestro rechargeable system on (b)(6) 2017. Because the anterior lead was twisted with the posterior lead, all device components were replaced. Revision procedure was successfully completed without adverse impact to subject. Explanted device components have not yet been received by enteromedics. Reference mdr 3005025697-2017-00014 for report related to the posterior lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00001 |
| MDR Report Key | 6237397 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2017-01-10 |
| Date of Report | 2017-06-29 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2014-01-24 |
| Date Added to Maude | 2017-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RANDY HOYT |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6517892671 |
| Manufacturer G1 | ENTEROMEDICS, INC. |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO RECHARGEABLE SYSTEM |
| Generic Name | ANTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-01-10 |
| Returned To Mfg | 2017-06-01 |
| Model Number | 2200A-47E |
| Catalog Number | 2200A-47E |
| Lot Number | CR-01825 |
| Device Expiration Date | 2017-01-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTEROMEDICS, INC. |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-10 |